FDA 510(k) Application Details - DEN180059

Device Classification Name

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510(K) Number DEN180059
Device Name Nerivio Migra
Applicant Theranica Bioelectronics ltd
45 Hamelakha st. Poleg Industrial Park
Netanya 4250574 IL
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Contact Alon Ironi Ironi
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Regulation Number

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Classification Product Code QGT
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Date Received 11/06/2018
Decision Date 05/20/2019
Decision DENG -
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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